# K020801: Quickvue One-Step HCG-Combo

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: May 17, 2002 after 66 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K032563: Clinitest HCG Pregnancy Test (2003), 7 descendants of its own
- K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 (2009), 6 descendants of its own
- K132834: Fastep S10 HCG Serum/Urine Combo Test (2014), 3 descendants of its own
- K203272: Alltest Pregnancy Rapid Combo Test Cassette (2022), 2 descendants of its own
- K141874: Uriscan Optima (2015), 2 descendants of its own

## Indications for use
The QuickVue One-Step hCG-Combo is a one-step immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The test is intended for use by health care professionals.

Source page: https://510kreport.com/device/K020801
Methodology: https://510kreport.com/methodology